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Generated: May 23, 2019

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Details for New Drug Application (NDA): 018561

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NDA 018561 describes DEXTROSE 70% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, and Icu Medical Inc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the DEXTROSE 70% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 70% IN PLASTIC CONTAINER is dextrose. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 018561
Applicant:Icu Medical Inc
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018561
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 70% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 018561 NDA Hospira, Inc. 0409-7918 0409-7918-19 12 POUCH in 1 CASE (0409-7918-19) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength70GM/100ML
Approval Date:Mar 23, 1982TE:APRLD:Yes

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